Randomized Trial of Tacrolimus Versus Cyclosporine in Steroid Withdrawal in Living Donor Renal Transplant Recipients / 대한신장학회잡지

ABSTRACT

BACKGROUND: The introduction of new immunosuppressants has prompted several trials of steroid withdrawal immunosuppression. However, several groups have reported a higher incidence of rejection. METHODS: We conducted a randomized two-arm, parallel group, open label, prospective study to compare steroid withdrawal (at 6 months post-transplant) regimens tacrolimus+mycophenolate mofetil (MMF) (FK group) vs cyclosporine+MMF (CyA group). Entry criteria were first living donor transplant recipient, no diabetes mellitus (DM), no congestive heart failure, no chronic liver disease, and no acute rejection by 6 months post-transplant. The primary endpoint was a biopsy-proven acute rejection episode or treatment failure within 1 year post- transplant. RESULTS: While eighty-seven recipients were assigned to FK (n=43) and CyA group (n=44) before transplantation, seventy-six recipients (FK 39, CyA 37) could taper off steroid at 6 months post-transplant since eleven were excluded due to acute rejection within 6 months post-transplant (FK 2, CyA 3), protocol violation (FK 2, CyA 1), drug change due to side effect (CyA 2) and follow-up loss (CyA 1). After steroid withdrawal, acute rejection episode was 0% in FK group and 13.5% in CyA group (p0.05 in every variable). CONCLUSION: These data suggest that steroid withdrawal are successful in first living donor renal transplant recipients and tacrolimus may be more effective than cyclosporine significantly in preventing acute rejection after steroid withdrawal.